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RecruitingPhase 3

A Study to Assess the Efficacy and Safety of Subcutaneous Induction Therapy With Afimkibart in Participants With Moderately to Severely Active Ulcerative Colitis

Hoffmann-La Roche · with Chugai Pharmaceutical, Pfizer · NCT07846683

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 16–80 · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 3
Target enrollment
350
US sites recruiting
1
Study start
November 15, 2026
Record last updated
October 26, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

The purpose of this study is to assess the efficacy and safety of subcutaneous induction with afimkibart in participants with moderately to severely active ulcerative colitis (UC).

Being studied: Afimkibart; Placebo

Conditions: Moderately to Severely Active Ulcerative Colitis

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Inclusion Criteria

  • Confirmed diagnosis of UC.
  • Moderately to severely active UC assessed by modified Mayo Score (mMS).
  • Bodyweight >= 40 kilogram (kg).
  • Up to date with colorectal cancer (CRC) screening performed according to local standards.
  • Demonstrated inadequate response, loss of response and/or intolerance to at least one protocol-specified conventional or advanced UC therapy.
  • Females of childbearing potential must meet protocol criteria for contraception requirements.

Exclusion Criteria

  • Currently known complications of UC (e.g. fulminant colitis, toxic megacolon).
  • Current diagnosis of Crohn's disease (CD) or indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis.
  • Presence of an ostomy or ileoanal pouch.
  • Current diagnosis or suspicion of primary sclerosing cholangitis.
  • Pregnancy or breastfeeding, or intention of becoming pregnant during the study.
  • Past or current evidence of definite low-grade or high-grade colonic dysplasia or adenomas or neoplasia not completely removed.
  • History of malignancy within 5 years, with the exception of malignancies adequately treated with resection for non-metastatic basal cell or squamous cell cancer or in situ cervical cancer.
  • Evidence of infection with Clostridioides difficile (C. difficile; formerly known as Clostridium difficile), cytomegalovirus (CMV), human immunodeficiency virus (HIV), Hepatitis B (HBV), Hepatitis C (HCV).
  • Has evidence of active tuberculosis (TB), latent TB not successfully treated (per local guidance) or inadequately treated TB.
  • Has received protocol-specified prohibited medicines, including known exposure to any type of anti-TL1A therapy.

Recruiting US locations

Study contacts (from the official record)

  • Reference Study ID Number: CA46523 https://forpatients.roche.com/ No attachments to email below. · 888-662-6728 (U.S. and Canada) · global-roche-genentech-trials@gene.com
  • Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry
A Study to Assess the Efficacy and Safety of Subcutaneous… (NCT07846683) | Bored Studies